Active Ingredient
Benzoyl Peroxide 10%
Spot On Treatment
FDA Label NDC 72644-636
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sgii, Inc for the product Spot On Treatment (NDC 72644-636). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Uses
For the treatment of Acne
Warnings
For External Use Only
Keep Out Of Eyes
Otc - When Using
When using this product • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
Otc - Do Not Use
Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide
Otc - Stop Use
Stop use and ask a doctor if • irritation becomes severe.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•Clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three
times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredients
Aqua/Water/Eau, Aloe Vera (Aloe Barbadensis) Leaf Juice, Dimethyl Isosorbide, Polyacrylamide, C13-14 Isoparaffin, Menthoxypropanediol, Laureth-7, Phenoxyethanol, Propanediol, Sodium Citrate, Allantoin, Bisabolol, Caprylyl Glycol, Diethylhexyl Sodium Sulfosuccinate, Panthenol, Carbomer, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Ginger (Zingiber Officinale) Root Extract
* Please review the disclaimer below.
